BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STENT - VASCULAR RECONSTRUCTION

    MDR report key: 16923410 · Received May 12, 2023

    Report

    Report Number
    3008114965-2023-00291
    Event Type
    Injury
    Date Received
    May 12, 2023
    Date of Event
    July 31, 2012
    Report Date
    May 12, 2023
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    NJE
    PMA / PMN Number
    H60001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S REF. NO: (B)(4). THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: DÁVALOS A, PEREIRA VM, CHAPOT R, BONAFÉ A, ANDERSSON T, GRALLA J; SOLITAIRE GROUP. RETROSPECTIVE MULTICENTER STUDY OF SOLITAIRE FR FOR REVASCULARIZATION IN THE TREATMENT OF ACUTE ISCHEMIC STROKE. STROKE. 2012 OCT;43(10):2699-705. DOI: 10.1161/STROKEAHA.112.663328. EPUB 2012 JUL 31. PMID: 22851547. SECTION D.4: THE PRODUCT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE / NOT REPORTED. THE UNIQUE IDENTIFIER (UDI) AND EXPIRATION DATE OF THE DEVICE IS NOT KNOWN. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. SINCE THIS EVENT REQUIRED MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION FOR TREATMENT OR PREVENTION OF PERMANENT DAMAGE TO THE PATIENT, THIS EVENT IS MDR REPORTABLE. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE AND THE FOLLOWING CITATION WAS REVIEWED: DÁVALOS A, PEREIRA VM, CHAPOT R, BONAFÉ A, ANDERSSON T, GRALLA J; SOLITAIRE GROUP. RETROSPECTIVE MULTICENTER STUDY OF SOLITAIRE FR FOR REVASCULARIZATION IN THE TREATMENT OF ACUTE ISCHEMIC STROKE. STROKE. 2012 OCT;43(10):2699-705. DOI: 10.1161/STROKEAHA.112.663328. EPUB 2012 JUL 31. PMID: 22851547. OBJECTIVE AND METHODS: THE PURPOSE OF THIS RETROSPECTIVE STUDY WAS TO EVALUATE THE SAFETY AND EFFICACY OF THE SOLITAIRE FR DEVICE IN THE TREATMENT OF PATIENTS WITH ACUTE ISCHEMIC STROKE SECONDARY TO LARGE ARTERY OCCLUSION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED CERENOVUS DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: ENTERPRISE. OTHER CONCOMITANT CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. NON-CERENOVUS DEVICES THAT WERE ALSO USED IN THIS STUDY: N/A. ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: ONE PATIENT EXPERIENCED CEREBRAL ISCHEMIA AFTER INTRASTENT THROMBOSIS OF THE ENTERPRISE STENT PLACED TO TREAT THE DISSECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1357506 STENT - VASCULAR RECONSTRUCTION INTRACRANIAL NEUROVASCULAR STENT NJE MEDOS INTERNATIONAL SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening